CONTROLLED TRIAL OF SOTALOL FOR ONE YEAR AFTER MYOCARDIAL INFARCTION

doi:10.1016/S0140-6736(82)92225-5

The Lancet

Volume 319, Issue 8282, 22 May 1982, Pages 1142-1147

https://doi.org/10.1016/S0140-6736(82)92225-5 Get rights and content

Abstract

In a multicentre double-blind randomised study, the effect of sotalol 320 mg once daily was compared with that of placebo in patients surviving an acute myocardial infarction. Treatment was started 5-14 days after infarction in 1456 patients (60% being randomised to sotalol, and 40% to placebo) who represented 45% of those evaluated for entry. Patients were followed for 12 months. The mortality rate was 7·3% (64 patients) in the sotalol group and 8·9% (52 patients) in the placebo group. The mortality was 18% lower in the sotalol than in the placebo group, but this difference was not statistically significant. The rate of definite myocardial reinfarction was 41% lower in the sotalol group than in the placebo group (p<0·05). Although the differences in mortality were not significant, this trial supports the evidence that, in the year after myocardial infarction, beta adrenoceptor blocking drugs reduce mortality by 20-25%.

References (12)

G. Ahlmark et al.
Reduction of sudden deaths after myocardial infarction
Lancet
(1974)
C. Wilhelmsson et al.
Reduction of sudden deaths after myocardial infarction by treatment with alprenolol
Lancet
(1974)
Multicentre International Study: Supplementary Report Reduction in mortality after myocardial infarction with long-term beta-adrenoceptor blockade
Br Med J
(1977)
Coronary Protect Research Group (CPRG)
Secondary prevention studies with oxprenolol in coronary heart disease
Jm Barber et al.
Practolol in acute myocardial infarction
Acta Med Scand
(1976)

There are more references available in the full text version of this article.

Cited by (354)

Association of sotalol versus atenolol therapy with survival in dogs with severe subaortic stenosis
2023, Journal of Veterinary Cardiology
Dogs with severe subaortic stenosis (SAS) are at risk of dying suddenly from fatal arrhythmias. Survival is not improved when treated with pure beta-adrenergic receptor (β)-blockers; however, the effect of other antiarrhythmic drugs on survival is unknown. Sotalol is both a β-blocker and a class III antiarrhythmic drug; the combination of these differing mechanisms may provide benefit to dogs with severe SAS. The primary objective of this study was to compare survival in dogs with severe SAS that were treated with either sotalol or atenolol. The secondary objective was to evaluate the effect of pressure gradient (PG), age, breed, and aortic regurgitation on survival.
Forty-three client-owned dogs.
Retrospective cohort study. Medical records of dogs diagnosed with severe SAS (PG ≥ 80 mmHg) between 2003 and 2020 were reviewed.
No statistical difference was identified in survival time between dogs treated with sotalol (n=14) and those treated with atenolol (n=29) when evaluating all-cause mortality (p=0.172) or cardiac-related mortality (p=0.157). Of the dogs that died suddenly, survival time was significantly shorter in dogs treated with sotalol compared to those treated with atenolol (p=0.046). Multivariable analysis showed that PG (p=0.002) and treatment with sotalol (p=0.050) negatively influenced survival in the dogs that died suddenly.
Sotalol did not have a significant effect on survival overall but may increase the risk of sudden death in dogs with severe SAS compared to atenolol.
Sotalol
2016, Cardiac Electrophysiology Clinics
Initiation of β-blocker therapy and depression after acute myocardial infarction
2016, American Heart Journal
Although β-blockers reduce mortality after acute myocardial infarction (AMI), early reports linking β-blocker use with subsequent depression have potentially limited their use in vulnerable patients. We sought to provide empirical evidence to support or refute this concern by examining the association between β-blocker initiation and change in depressive symptoms in AMI patients.
Using data from 2 US multicenter, prospective registries of AMI patients, we examined 1-, 6-, and 12-month changes in depressive symptoms after the index hospitalization among patients who were β-blocker–naïve on admission. Depressive symptoms were assessed using the validated 8-item Patient Health Questionnaire (PHQ-8), which rates depressive symptoms from 0 to 24, with higher scores indicating more depressive symptoms. A propensity-matched repeated-measures linear regression model was used to compare change in depressive symptoms among patients who were and were not initiated on a β-blocker after AMI.
Of 3,470 AMI patients who were β-blocker–naïve on admission, 3,190 (91.9%) were initiated on a β-blocker and 280 (8.1%) were not. Baseline PHQ-8 scores were higher in patients not initiated on a β-blocker (mean 5.78 ± 5.45 vs 4.88 ± 5.11, P = .005). PHQ-8 scores were progressively lower at 1, 6, and 12 months in both the β-blocker (mean decrease at 12 months 1.16, P < .0001) and no–β-blocker groups (mean decrease 1.71, P < .0001). After propensity matching 201 untreated patients with 567 treated patients, initiation of β-blocker therapy was not associated with a difference in mean change in PHQ-8 scores at 1, 6, or 12 months after AMI (absolute mean difference with β-blocker initiation at 12 months of 0.08, 95% CI −0.81 to 0.96, P = .86).
Initiation of β-blocker therapy after AMI was not associated with an increase in depressive symptoms. Restricting β-blocker use because of concerns about depression appears unwarranted and may lead to undertreatment of AMI patients.
Drug Treatment of Stable Coronary Artery Disease
2016, Translational Research in Coronary Artery Disease: Pathophysiology to Treatment
Patients with stable coronary artery disease should have their modifiable coronary risk factors intensively treated. Hypertension should be treated with beta-blockers and angiotensin-converting enzyme inhibitors. Patients should be treated with high-dose statins. Diabetics should have their hemoglobin A_1c reduced to <7.0%. Body mass index should be 18.5–24.9 kg/m². Regular aerobic exercise should be performed. Aspirin or clopidogrel, beta-blockers, and ACE inhibitors should be administered unless there are contraindications. Long-acting nitrates are effective antianginal and antiischemic drugs. Calcium channel blockers and ranolazine may be added if angina persists despite beta-blockers and long-acting nitrates. Hormonal replacement therapy should not be given to postmenopausal women. A cardiac rehabilitation program is recommended. Annual vaccination against influenza is recommended. The two indications for coronary revascularization are prolongation of life and relief of unacceptable symptoms despite optimal medical management.
Long-term use of cardiovascular drugs challenges for research and for patient care
2015, Journal of the American College of Cardiology
Little is known about the benefits and risks of the long-term use of cardiovascular drugs. Evidence from randomized clinical trials (RCTs) rarely goes beyond a few years of follow-up, but patients are often given continuous treatment with multiple drugs well into old age. We focus on 4 commonly used cardiovascular drug classes: aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors given to patients after myocardial infarction. However, the issues raised apply more broadly to all long-term medications across cardiovascular diseases and the whole of medicine. The evidence and limitations of RCTs are addressed, as well as current practice in pre-licensing trials, the increasing problems of polypharmacy (especially in the elderly), the lack of trial evidence for withdrawal of drugs, the role of regulatory authorities and other stakeholders in this challenging situation, and the potential educational solutions for the medical profession. We conclude with a set of recommendations on how to improve the situation of long-term drug use.
Clinical outcomes with β-blockers for myocardial infarction: A meta-analysis of randomized trials
2014, American Journal of Medicine
Debate exists about the efficacy of β-blockers in myocardial infarction and their required duration of usage in contemporary practice.
We conducted a MEDLINE/EMBASE/CENTRAL search for randomized trials evaluating β-blockers in myocardial infarction enrolling at least 100 patients. The primary outcome was all-cause mortality. Analysis was performed stratifying trials into reperfusion-era (> 50% undergoing reperfusion or receiving aspirin/statin) or pre-reperfusion-era trials.
Sixty trials with 102,003 patients satisfied the inclusion criteria. In the acute myocardial infarction trials, a significant interaction (P_interaction = .02) was noted such that β-blockers reduced mortality in the pre-reperfusion (incident rate ratio [IRR] 0.86; 95% confidence interval [CI], 0.79-0.94) but not in the reperfusion era (IRR 0.98; 95% CI, 0.92-1.05). In the pre-reperfusion era, β-blockers reduced cardiovascular mortality (IRR 0.87; 95% CI, 0.78-0.98), myocardial infarction (IRR 0.78; 95% CI, 0.62-0.97), and angina (IRR 0.88; 95% CI, 0.82-0.95), with no difference for other outcomes. In the reperfusion era, β-blockers reduced myocardial infarction (IRR 0.72; 95% CI, 0.62-0.83) (number needed to treat to benefit [NNTB] = 209) and angina (IRR 0.80; 95% CI, 0.65-0.98) (NNTB = 26) at the expense of increase in heart failure (IRR 1.10; 95% CI, 1.05-1.16) (number needed to treat to harm [NNTH] = 79), cardiogenic shock (IRR 1.29; 95% CI, 1.18-1.41) (NNTH = 90), and drug discontinuation (IRR 1.64; 95% CI, 1.55-1.73), with no benefit for other outcomes. Benefits for recurrent myocardial infarction and angina in the reperfusion era appeared to be short term (30 days).
In contemporary practice of treatment of myocardial infarction, β-blockers have no mortality benefit but reduce recurrent myocardial infarction and angina (short-term) at the expense of increase in heart failure, cardiogenic shock, and drug discontinuation. The guideline authors should reconsider the strength of recommendations for β-blockers post myocardial infarction.

View all citing articles on Scopus

View full text

CONTROLLED TRIAL OF SOTALOL FOR ONE YEAR AFTER MYOCARDIAL INFARCTION

Abstract

Lancet

Reduction of sudden deaths after myocardial infarction by treatment with alprenolol

Lancet

Multicentre International Study: Supplementary Report Reduction in mortality after myocardial infarction with long-term beta-adrenoceptor blockade

Br Med J

Secondary prevention studies with oxprenolol in coronary heart disease

Practolol in acute myocardial infarction

Acta Med Scand